A new implanted sternal device system for pediatric patients is contraindicated for MRI. Age < 21 J American College of Surgeons. General Precautions: The LINX device is a long-term implant. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. LINX Reflux Management System, Implant Clasp, 13-16 Bead, 1.5T, Product Code LXM-xx, sterile, Rx only. Instructions for use are found in the information that accompanied the product packaging. Implantable Pediatric Sternum Device. This site is published by Ethicon US, LLC, which is solely responsible for its contents, and is intended for U.S. audiences only. Maximum spatial gradient of the static magnetic field specification must be ≤25 T/m (2500 gauss/ cm). 3: Conditional 5 More... ActiFlo Indwelling Bowel Catheter System More... ActiGait Implantable Drop Foot Stimulator Neurostimulation System Ottobock, www.ottobock.com . Patients implanted with t, LINX Reflux Management System Torax Medical www.toraxmedical.com, https://www.jnjmedicaldevices.com/en-US/service-details/LINX-diagnostic-imaging?fbclid=IwAR1-gr_C7cEeZGI_BjbYG9muXsG3LY2lUYASH0y3wc_Z. device explant due to the device opening occurred without issue on (b)(6) 2018. A Revolutionary Treatment for Reflux Disease. Based on a study observing 100 patients who were implanted with LINX, daily use of PPIs  decreased to 15.3% at 5 years. Linx products make it simple for engineers and hobbyists to integrate wireless features without the hassle and expense of engineering RF functionality from scratch. What MRI safety information does the labeling contain? 360° Restore, don't reconstruct 12. The LINX® Reflux Management System is a laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who are seeking an alternative to continuous acid suppression therapy (i.e. Weight gain can sometimes cause problems with the Linx device because it puts pressure on the stomach. Search by the product name (Reveal LINQ) or model number (LNQ11). The safety and effectiveness of the LINX Reflux Management System has not been established for the following conditions: Scleroderma Global Unique Device ID: 00855106005356. Please visit linxforlife.com for additional information. See a short video on how LINX ® works. Welcome to Linx Support. 1,2,3 The longevity of LINX will remain uncertain for at least another five to 10 years. Working as one Limb, Linx delivers an experience that mimics the incredible and complex structure of the human leg by actively sensing and analyzing data on the user movement, activity, environment and terrain providing a coordinated stream of instructions to the hydraulic support system. 14(5):671-7. Video esophagram on (b)(6) 2018 found that "the linx band is discontinuous allowing free esophageal reflux. There are two versions of the LINX® device. There was no evidence of a hiatal hernia, gastro esophageal reflux, or esophagitis at the time. Based on a retrospective analysis of 1-year outcomes of patients undergoing MSA and LNF from June 2010 to June 2013. € Ganz R. Edmundowicz S, Taiganides P, et al. Warnings: The LINX device is considered MR Conditional in a magnetic resonance imaging (MRI) system up to either 0.7 Tesla (0.7T) or 1.5 Tesla (1.5T), depending on the LINX model implanted. MR Conditional Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): No Device labeled as "Not made with natural rubber latex": No For Single-Use: Yes Prescription Use (Rx): Yes Over the Counter (OTC): Data and usage fees may apply. See your carrier for more information. LINX Reflux Management System Implant LINX System Torax Medical, www.toraxmedical.com IMPORTANT NOTE: It's important to know which LINX device a patient has prior to MRI. You are about to leave jnjmedicaldevices.com. If you are a patient, it is important that you discuss information about the benefits and risks of products with your doctor. With LINX ®, acid stays in the stomach, where it belongs. Linx France fait partie de la Division « Identification Produit » du Groupe Danaher, leader mondial dans les solutions industrielles de marquage. Can I have an MRI test after receiving the LINX Reflux Management System? You should discuss the MRI scanning options with your doctor prior to deciding on treatment with the LINX® system. MODEL SPECS. Diagnostic Imaging with LINX ®. Product Code LXM-13; b. Shellock R & D Services, Inc. email: Frank.ShellockREMOVE@MRIsafety.com. 221(1):123-128. 98.1% (p=0.118) and 97.8% of patients, respectively, reported symptom improvement or resolution. Alert Indications, Safety, ... Access prescriber, implant, MRI, and other manuals on the Medtronic Manual Library. Anti-reflux procedure including linx device implantation occurred on (b)(6) 2015. The LINX Reflux Management System a . MRI BIOEFFECTS, SAFETY, AND PATIENT MANAGEMENT is a comprehensive, authoritative textbook on the health and safety concerns of MRI technology that contains contributions from more than forty internationally respected experts in the field. The product information included here may not be appropriate for use outside the United States, and the information from other sites you visit may not be appropriate for use in the United States. Warnings: The LINX device is considered MR Conditional in a magnetic resonance imaging (MRI) system up to either 0.7 Tesla (0.7T) or 1.5 Tesla (1.5T), depending on the LINX model implanted. Laparoscopic Magnetic Sphincter Augmentation vs Laparoscopic Nissen Fundoplication: A Matched-Pair Analysis of 100 Patients. Suspected or confirmed esophageal or gastric cancer. We use cookies on this site to enhance your user experience. Clin Gastroenterol Hepatol. Mass. ‡ Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, bothersome heartburn was 89% at baseline and decreased to 11.9% at 5 years. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. MRI Absolute Contraindications . The Epic stented tissue valve with Linx™ anticalcification (AC) technology is engineered to deliver excellent durability and performance, as well as smooth, streamlined implantability. * The LINX Reflux Management System is a flexible ring of small magnets placed around the LES during a minimally invasive procedure. ‡‡ Reynolds J, Zehetner J, Wu P, et al. † Based on 192 patients who underwent MSA with LINX as well as a matched pair analysis in which 47 patients underwent MSA2. Safety Info ID# Safety Topic / Subject Article Text 351: LINX Reflux Management System (Torax Medical, Inc., www.toraxmedical.com) LINX Reflux Management System. You should discuss the MRI scanning options with your physician prior to deciding on treatment with LINX®. Hydrogen proton MRI equipment must be used. Over many years, we have developed world-class expertise in machine vision, real-time control, PLC / motion, and different software development tools. Scanning under different conditions may result in serious injury to you and/or interfere with the magnetic strength and the function of the device. Gastroesophageal Reflux Disease (GERD) is a chronic, often progressive disease resulting from a weak lower esophageal sphincter (LES). LINX® patients may undergo magnetic resonance imaging (MRI) up to either 0.7 – Tesla (0.7T) or 1.5 – Tesla (1.5T) depending on the LINX® model implanted. Patient began experiencing gerd. 14(5):671-7. †† Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, the success criteria for quality of life  (50% reduction in total GERD-HRQL score, and  PPI use 50% reduction) were met. Contraindications: Do not implant the LINX Reflux Management System in patients with suspected or known allergies to titanium, stainless steel, nickel, or ferrous materials. Scanning under different conditions may result in serious injury to you and/or interfere with the magnetic strength and the function of the device. * Based on a 5-year study observing 100 patients who were implanted with LINX. 2016. ** Ganz R. Edmundowicz S, Taiganides P, et al. 221(1):123-128. 5 Long-term outcomes are known for both anterior and posterior partial fundoplication variants, with success rates of more than 85 percent at 10 to 20 years follow-up reported in randomized trials. MRI Safety » MRI Absolute Contraindications. Indications, Safety & Warnings; Clinician Education Clinical Evidence Resources and Support ... Horizontal cylindrical bore magnet, clinical MRI systems with a static magnetic field of 1.5 Tesla (T) or 3.0 T must be used. The company started implanting LINX units safe to 1.5T after that date, and those implant cards are blue in color. Morbid obesity. Unlike standard surgical treatments for GERD, the LINX system uses a tiny bracelet of magnetic titanium beads to surround and compress the lower esophageal sphincter, a band of muscle that normally prevents stomach fluids from backing into the esophagus. Dimensions. Laparoscopic Magnetic Sphincter Augmentation vs Laparoscopic Nissen Fundoplication: A Matched-Pair Analysis of 100 Patients. (BMI >35) Linx supplies a comprehensive range of support documentation and materials with every product to explain how to operate the equipment and carry out routine maintenance. A steel oxygen tank is never permitted inside of the MRI system room. Brand Name: LINX Reflux Management System. 360° Retained ability to belch and vomit 13. Copyright © 2021 by Shellock R & D Services, Inc. and Frank G. Shellock, Ph.D. All rights reserved. In a study of 100 patients implanted with LINX, bothersome heartburn decreased to 11.9% (p<0.001) and bothersome regurgitation decreased to 1.2% (p<0.001). Scanning under different conditions may result in serious injury to you and/or interfere with the magnetic strength and the function of the device. Clin Gastroenterol Hepatol. Other risks reported after anti-reflux surgery procedures include bloating, nausea, dysphagia (difficulty swallowing), odynophagia (painful swallowing), retching, and vomiting. Management of adverse reactions may include explantation and/or replacement. All contents © Medical Devices Business Services, Inc. 2021. One is safe in MRI scanning machines up to 0.7T, the other is safe to 1.5T. Labeled as: a. This site uses cookies as described in our, LINX Reflux Management System Dr John Pandolfino reviews CALIBER Video, The LINX Reflux Management System Procedure - Dr. Blair A. Jobe, MD, The LINX Reflux Management System Tissue Encapsulation, The LINX Reflux Management System Short Procedure, The LINX Reflux Management System Yield Pressure, Dr John Lipham Reviews LINX outcomes in Patients with Large Hiatal Hernias. Shoreview, Minnesota 55126, USA. Distal esophageal motility less than 35mmHg peristaltic amplitude on wet swallows or <70% (propulsive) peristaltic sequences or High Resolution Manometry equivalent, and/or a known motility disorder such as Achalasia, Nutcracker Esophagus, and Diffuse Esophageal Spasm or Hypertensive LES. J American College of Surgeons. The safety and effectiveness of the LINX device has not been evaluated in patients with Barrett's esophagus or Grade C or D (LA classification) esophagitis. © Ethicon US, LLC. §§ Reynolds J, Zehetner J, Wu P, et al. Since the LINX system contains magnetic metals, there is a good chance that you’ll experience serious internal injuries if you go in for an MRI. Site development supported by Unrestricted Educational Grant from Bracco: LINX Reflux Management System (Torax Medical, Inc., www.toraxmedical.com). Esophageal or gastric varices. Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, there was a significant improvement in the median GERD-HRQL score at 5 years, as compared with  baseline, both with and without PPI use, 4 vs 11 and 27 respectively (p<0.001). Laparoscopic placement of the LINX device is major surgery and death can occur. 1.2 cc. Close Cookie Statement . You may at any time change the settings regarding cookies. proton pump inhibitors or equivalent) in the management of their GERD. Failure to follow these conditions for use may result in a hazard to the patient during an MRI scan: Hydrogen proton MRI equipment must have a static magnetic field of 1.5 Tesla (T) or 3.0 T. Those patients have a white implant device card. The LINX® Reflux Management System (Torax Medical, Inc., Shoreview, MN, USA) is comprised of a small expandable ring of linked magnetic beads. Hardbound MRI Textbook. Reveal LINQ™ Insertable Cardiac Monitor MRI Conditions for Use. In the event alternative diagnostic procedures cannot be used and MRI is required, the LINX device can be safely removed utilizing a laparoscopic technique that does not compromise the option for traditional anti-reflux procedures. 4188 Lexington Avenue North 085133-171129 Call our UCI Health GERD specialists for a consultation today at 888-717-GIMD (888-717-4463). Explant (removal) and replacement surgery may be indicated at any time. The third-party trademarks used herein are trademarks of their respective owners. Device Name: . In addition, the magnetic field produced by an MRI machine could interfere with the magnetic bonds in the beads, rendering them ineffective. 2019. For product support, downloads and technical information for the Linx range of tablets and notebooks, please select your device from the choices below. Matched-pair analysis of 100 patients. The Reveal LINQ™ device can be safely scanned in patients under the following conditions. Linx also offers an extensive line of antennas, connectors and … Based on the GERD-HRQL. Based on a retrospective analysis of 1-year outcomes of patients undergoing MSA and LNF from June 2010 to June 2013. Manufactured by: This information is intended for use by customers, patients, and healthcare professionals in the United States only. Potential Side Effects: Potential adverse events associated with laparoscopic surgery and anesthesia include adverse reaction to anesthesia (headache, muscle pain, nausea), anaphylaxis (severe allergic reaction), cardiac arrest, death, diarrhea, fever, hypotension (low blood pressure), hypoxemia (low oxygen levels in the blood), infection, myocardial infarction, perforation, pneumonia, pulmonary embolism (blood clot in the lung), respiratory distress, and thrombophlebitis (blood clot). MR Conditional Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437): No Device labeled as "Not made with natural rubber latex": No For Single-Use: Yes Prescription Use (Rx): Yes Over the Counter (OTC): Displaying 1 - 2 of 2. 14(5):671-7. 2015. Some are essential to make our site work; others help us improve the user experience. The LINX device has not been evaluated in patients with an unrepaired hiatal hernia greater than 3cm. Floor polishers are poor MRI system cleaners! 2015. 4.3% of MSA patients were unable to vomit when necessary compared to 21.3% of LNF patients (p = 0.004). I should point out that the LINX devices implanted before May 22, 2015 were MRI safe up to 0.7T. 84 subjects were followed up for 5 years, baseline dissatisfaction was 95% and decreased to 7.1% in year 5 (p < .001). Last updated February 20, 2019. Demonstrated efficacy with a favourable safety profile 11. This site uses cookies to store information on your computer. Prior esophageal or gastric surgery or endoscopic intervention. Early LINX data does not appear to match these outcomes. ** Achieved target reduction in GERD-HRQL score in 83% of patients, and target reduction in PPI usage in 89% of patients.†† Improvement in patient satisfaction at 5 years.€ The device maintains normal gastroesophageal junction and gastric anatomy and preserves physiologic function (belch and vomit).‡‡ Low incidence of side effects.§§, FENIX Product Discontinuation Information. When patients swallow, the LINX Reflux Management System opens temporarily to allow food and liquid to pass into the stomach. Go ahead, let it out. Dr. Michael Harrison (pediatric surgery UCSF) is currently running a phase 2 research procedure, The Magnetic Mini-Mover procedure. We recognize that the Internet is a global communications medium; however, laws, regulatory requirements, and product information for medical products can vary from country to country. LINX® Reflux Management System Important Safety Information. All Rights Reserved. (p<0.001), ¶ Ganz R. Edmundowicz S, Taiganides P, et al. Failure to secure the LINX device properly may result in its subsequent displacement and necessitate a second operation. It keeps harmful stomach acid from flowing back up into the esophagus, where it can cause painful heartburn and damage. Mild low-grade esophagitis suspected. " The device is laparoscopically implanted around the esophagus at the esophagogastric junction to mechanically augment the function of the lower esophageal sphincter (LES) for the treatment of gastroesophageal reflux disease (GERD).Each bead in the LINX device cont… For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert. What MRI safety information does the labeling contain? LINX ® is a small, flexible ring placed around the lower esophagus, right above the opening to the stomach. It is recommended that patients receiving the LINX device register their implant with the MedicAlert Foundation (www.medicalert.org) or equivalent organization. Esophagram on (b)(6) 2018 visualized the discontinuous device. Warnings: The LINX device is considered MR Conditional in a magnetic resonance imaging (MRI) system up to either 0.7 Tesla (0.7T) or 1.5 Tesla (1.5T), depending on the LINX model implanted. Reveal LINQ LNQ11 Specifications. The LINX Reflux Management System a, LINX Reflux Management System Implant LINX System Torax Medical, www.toraxmedical.com IMPORTANT NOTE: It's important to know which LINX device a patient has prior to MRI. By using the site, you consent to the placement of these cookies. The safety and effectiveness of the LINX device has not been evaluated in patients with electrical implants such as pacemakers and defibrillators, or other metallic, abdominal implants. 8.5% of MSA patients were unable to belch, compared to 25.5% of LNF patients (p = 0.028). Patients with a LINX ® device can safely undergo a wide range of diagnostic imaging tests, including: X-Ray, ultrasound, PET scan, CT scan and MRI.. Are you considering LINX ®?. LINX® patients can also undergo: CT Scan, Ultrasound, X-Ray and PET Scan. About 10% of Linx patients still have to take medications after the procedure. There were no patients with severe gas and bloating in the MSA group compared with 10.6% in the LNF group (p=0.022). Gastroesophageal Reflux Disease (GERD) is a chronic, often progressive disease resulting from a weak lower esophageal sphincter (LES). LINX is an expert and industry-leader in the distribution of the world’s most advanced machine vision and automation products into the Japanese market. Linx patients cannot have MRI’s because it can cause damage to the linx device that was implanted in you. Long-term Outcomes of Patients Receiving a Magnetic Sphincter Augmentation Device for Gastroesophageal Reflux. Torax® Medical, Inc. Symptoms of dysphagia more than once per week within the last 3 months. DESCRIPTION SPECS; Volume. Unlike other procedures to treat reflux, LINX is implanted around the outside of the Lower Oesophageal Sphincter (LOS) and requires no alteration to the stomach. Safety Topic / Subject ActiFlo Indwelling Bowel Catheter System also known as Zassi Bowel Management System Hollister Incorporated Libertyville, IL. More LNF patients were unable to belch (8.5% of MSA and 25.5% of LNF; p= 0.028) or vomit (4.3% of MSA and 21.3% of LNF; p=0.004). Product Code LXM-14; c. Product Code LXM-15; d. Product Code LXM-16; Laparoscopic, fundic-sparing anti-reflux procedure indicated for patients diagnosed with Gastroesophageal Reflux Disease (GERD) as defined by abnormal pH testing, and who … Esophageal stricture or gross esophageal anatomic abnormalities. Lactating, pregnant or plan to become pregnant. Requires no permanent anatomic alteration to restore the reflux barrier. Reproducible Procedure, Consistent Results†, Demonstrated consistent symptom improvement across multiple studies.† 88% of patients reported that bothersome heartburn had been eliminated 5 years after treatment with the LINX Reflux Management System.‡ 85% of patients were free from dependence on daily reflux medication after treatment with the LINX Reflux Management System.§ 99% of patients eliminated regurgitation at 5 years.¶, Sustained Improvement in HRQL at 5 Years**, Patients reported significant improvement in quality of life after the LINX Reflux Management System. For complete indications, contraindications, warnings, precautions, and adverse reactions, please reference full package insert. A version of LINX ® considered MR Conditional in a magnetic resonance imaging (MRI) system up to 1.5 Tesla (1.5T) is now available. You may also call 800-961-9055 for a copy of a manual. Scanning under different conditions may result in serious injury to you and/or interfere with the magnetic strength and the function of the device. Device explant due to the device opening occurred without issue on (b)(6) 2018. The use of the LINX device in patients with a hiatal hernia larger than 3cm should include hiatal hernia repair to reduce the hernia to less than 3cm. Based on a 5 year prospective, multi-center, single-arm study observing 100 patients who were implanted with LINX, regurgitation was 57% at baseline and decreased to 1.2% at 5 years. Clin Gastroenterol Hepatol. Bothersome heartburn was 89% at baseline and decreased to 11.9% at 5 years(p<0.001), bothersome regurgitation was 57% at baseline and decreased to 1.2% at 5 years (p<0.001), PPI dependence decreased to 15.3% at 5 years (p<0.001). The procedure usually takes less than one hour to perform. Company Name: Torax Medical, Inc.. 2016. An office chair was in the wrong place - at ANY time!